Enhanced Bulbar Function in Amyotrophic Lateral Sclerosis: The Nuedexta Treatment Trial

Area of Science:

• Neurology
• Clinical Trials
• Pharmacology

Background:

• Amyotrophic lateral sclerosis (ALS) significantly impacts bulbar functions, including speech, swallowing, and salivation.
• Patient-reported improvements in bulbar symptoms while using Nuedexta for other conditions prompted this investigation.
• Existing treatments for ALS often focus on motor and respiratory functions, with limited options for bulbar dysfunction.

Purpose of the Study:

• To evaluate the efficacy of Nuedexta (dextromethorphan and quinidine) in enhancing speech, swallowing, and salivation in patients with ALS.
• To assess the impact of Nuedexta on self-reported and clinician-rated measures of bulbar function.
• To explore a potential new therapeutic role for Nuedexta in managing ALS-related bulbar symptoms.

Main Methods:

• A randomized, blinded, crossover clinical trial involving sixty patients diagnosed with amyotrophic lateral sclerosis (ALS).
• Participants received either Nuedexta or a placebo for 28–30 days, followed by a 10–15 day washout period before switching treatments.
• Primary endpoint: reduction in the self-report Center for Neurologic Study Bulbar Function Scale (CNS-BFS); Secondary endpoint: ALS Functional Rating Scale Revised (ALSFRS-R).

Main Results:

• Nuedexta treatment led to a significant improvement in the CNS-BFS score, decreasing from 59.3 (placebo) to 53.5 (Nuedexta) (p < 0.001).
• Individual bulbar domains showed significant improvement: salivation (p = 0.004), speech (p = 0.003), and swallowing (p = 0.009).
• The bulbar component of the ALSFRS-R also improved significantly (p = 0.003), while motor and respiratory components remained unaffected.

Conclusions:

• Nuedexta demonstrated significant efficacy in improving self-reported speech, swallowing, and salivation in patients with ALS.
• The study highlights the potential of Nuedexta as an adjunctive therapy for managing bulbar dysfunction in ALS.
• Further research is warranted to confirm these findings and establish Nuedexta's role in comprehensive ALS patient management.